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COLON CANCER SCREENING BY MEANS OF COLON CAPSULE ENDOSCOPY - A pilot study

COLON CANCER SCREENING BY MEANS OF COLON CAPSULE ENDOSCOPY - A pilot study - pilot CRC-screening by colon capsule endoscopy

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON45208
Enrollment
35
Registered
2013-11-11
Start date
2013-11-15
Completion date
Unknown
Last updated
2024-04-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

adenomas colorectal polyps/bowel cancer

Interventions

Participants are invited to capsule endoscopy screening using the Pillcam colon 2/2L (Given Imaging ltd. Israel). Colon cleansing consists of a tablet Bisacodyl 5 mg (Centrafarm BV) at bedtime 2 day
Norgine, Amsterdam, The Netherlands) and 2 liter transparent fluid, split-dose. Booster during CCE procedure consists of additional 250ml Eziclen boost and an optional 250ml Eziclen boost, each fol
it will take 5-10 minutes to complete one questionnaire.

Sponsors

Erasmus MC, Universitair Medisch Centrum Rotterdam
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: All consecutive ambulatory patients referred for a colonoscopy at the Gastroenterology and Hepatology Department of the Erasmus MC because of a suspicion of colorectal polyps or colorectal cancer or a positive iFOBT after participation in a FOBT-based CRC screening trial will be eligible for participation.

Exclusion criteria

Exclusion criteria: A potential subject who meets any of the following criteria will be excluded from participation in this study: - Inability or refusal to provide informed consent. - Persons with a severe or terminal disease with a life-expectancy of less than 5 years. - An allergy or any other known contraindication to the medication used in the study, including: - Renal failure, eGFR

Design outcomes

Primary

MeasureTime frame
The pilot study will focus completely on testing of the quality of the CCE procedure as intended in the screening trial. The main study parameters are feasibility and logistical shortcomings, efficacy of bowel preparation and understandability of information material.

Secondary

MeasureTime frame
n.a.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)